MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY OLYMPUS AFU-100 (100...240 V~); WB950167

Model Number	WB950167
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2024-0000439.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during an endoscopic submucosal dissection (esd) procedure the customer was seeing the e26 error on the device.It was stated that the problem affected the outcome of the procedure because the physician was unable to use the pump device properly to lift tissue for cutting.Additionally, there was a delay as there were many additional device exchanges to injection needles as they were needed to ¿lift tissue for cutting¿, which caused the procedure to take much longer.The second lesion site was also not attempted due to time constraints.Overall, the procedure was less successful than desired and not fully completed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide an update to field h4.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the subject device was not returned, and the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS AFU-100 (100...240 V~)
• Common Device Name: WB950167
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20446482
• Report Number: 3003724334-2024-00387
• Device Sequence Number: 8184028
• Product Code: GEI
• UDI-Device Identifier: 04042768501678
• UDI-Public: 04042768501678
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K073207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WB950167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARR-LOCKE NEEDLE.; DUALKNIFE (KD-655U)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown